• Shirish Shukla, Alok C Bharti, Showket Hussain, Sutapa Mahata, Suresh Hedau, Uma Kailash, Veena Kashyap, Suresh Bhambhani, Meera Roy, Swaraj Batra, G P Talwar, and Bhudev C Das.
• Division of Molecular Oncology, Institute of Cytology and Preventive Oncology (ICMR), Noida, India.
• J. Cancer Res. Clin. Oncol. 2009 Dec 1; 135 (12): 1701-9.

Purpose'Praneem', a polyherbal formulation developed by us, has successfully completed Phase II efficacy study for treatment of abnormal vaginal discharge due to reproductive tract infections that act as co-factors for HPV persistence. In the present study we evaluated potential anti-HPV activity of Praneem in women infected with high risk HPV type 16.MethodsTwenty women molecularly diagnosed positive for HPV16 infection without or with low grade squamous intraepithelial lesion (LSIL) or inflammation were assigned to receive intra-vaginal, topical application of either Praneem tablet or placebo for 30 days excluding the days of menstrual period and were evaluated for persistence of HPV infection using HPV L1 consensus and HPV type 16-specific PCR as primary outcome.ResultsOne course of Praneem treatment resulted in elimination of HPV in 6 out of 10 (60%) cases. A repeat treatment of four patients with persisting HPV infection resulted in clearance of HPV in two additional cases resulting in an overall 80% clearance of HPV 16 as against a spontaneous clearance of 10% (1/10) seen in the placebo arm. The elimination of HPV DNA was found to be accompanied by marked improvement in clinical symptoms and cytological abnormalities of Praneem-treated patients.ConclusionOur results showed for the first time that a 30-day intra-vaginal application of the Praneem can result in elimination of HPV infection from the uterine cervix.

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